Drug-Drug Interaction Study of Colchicine and Clarithromycin

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across membranes. This study will evaluate the effect of clarithromycin-related inhibition of CYP 3A4 and P-gp on the pharmacokinetics of colchicine. It will also evaluate the safety and tolerability of concurrent administration of clarithromycin and a single dose of colchicine.

Key facts

Study ID

NCT00984061

Run by

Mutual Pharmaceutical Company, Inc.

People needed

24

Starts

2007-11-01

Expected to finish

2008-01-01

Last updated by the study team

2009-10-15

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, non-smoking, adult volunteers, male and female, 18 to 45 years of age, weighing at least 55 kg and within 15% of ideal body weight, with hemoglobin >/=12 g/dL.
• Female volunteers must be sexually abstinent for 14 days prior to the first dose and throughout the study or using acceptable birth control methods (prior to and during the study), including being postmenopausal or surgically sterile (or sexual activity restricted to a partner that is surgically sterile), hormonal contraception, an IUD, or barrier methods with spermicide. Additionally, they will be advised to remain sexually inactive or to keep the same birth control method for at least 14 days following the last dose of colchicine.

You may not qualify if…

• Subjects who are pregnant or lactating
• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV)
• Have history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease; have used any drugs or substances known to inhibit or induce CYP enzymes and/or P-gp within 30 days prior to the first dose and throughout the study
• Recent (2-year) history of evidence of alcoholism or drug abuse
• Subjects who donated 50-499 ml of blood within 30 days and more than 499 ml within 56 days prior to the first dose; subjects who have donated in excess of 500 ml of blood in 14 days, 1500 ml or blood in 180 days, or 2500 ml of blood in 1 year (through completion of the study)
• Have participated in another clinical trial within 30 days prior to dosing
• Known and documented drug allergies to colchicine or macrolide antibiotics.

Where it is running

• PRACS Institute, Ltd. - Cetero Research — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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